Excimer Laser With Topical Agents in Psoriasis Vulgaris

Study Purpose

Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age: ≥18 years. 2. Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

Exclusion Criteria:

1. History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks. 2. Allergy to any ingredients of tretinoin or betamethasone drugs. 3. Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness. 4. Pregnancy, breast-feeding or women planning to become pregnant within 3 months. 5. Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment. 6. Patients with other diseases and requiring treatment that would affect the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05555797
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships. Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies . The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy . The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows. It is indicated in moderate to severe psoriasis that affects <10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose. The induration protocol compared with the others, allows to modify the dose with treatment. With this protocol, plaques achieved Psoriasis area and severity index (PASI-75) after 10 treatments . Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity. It has been shown to be effective for psoriasis treatment. However, its topical application is limited by its irritation. Studies have shown that combination with other lines may optimize the efficacy as well as minimize the local irritation due to TAZ. Betamethasone valerate (BV) is a high-potency, synthetic corticosteroid which acts on the intracellular glucocorticoid receptor. It also binds to membrane-bound receptors, enhancing its action. BV suppresses the production of inflammatory cytokines and reduces keratinocyte hyperproliferation.

Arms & Interventions

Arms

Experimental: group of patients with psoriasis vulgaris

in each patient lesions will be divided into 3 groups; Group 1: treated with Excimer laser alone(1-2 sessions/ week for 12 sessions according to induration protocol*). Group 2: treated with Excimer laser combined with topical tazarotene gel 0.1% Group3: treated with Excimer laser combined with topical betamethasone valerate ointment 0.1%

Interventions

Device: - 308nm Excimer laser

Excimer laser will be (1-2 sessions/ week for 12 sessions according to induration protocol)

Drug: - Tazarotene Topical Gel

Tazarotene gel 0.1%(finger tip unit of the gel) will be applied once daily for weeks

Drug: - Betamethasone Valerate

.Betamethasone valerate ointment 0.1% will be applied twice daily for 12 weeks.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Doaa S Sayed, professor

doaasamir1@yahoo.com

01143387171

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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